Coulter LH500 Series Analyzer, Part number: 178832, 178833, 178834. LH 500 Series System Instructions for Use, PN 624602 Rev BA. The COULTER LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter For In Vitro Diagnostic Use in clinical laboratories. The LH500 Analyzer also provides a semi-automated reticulocyte analysis.
FDA Recall Z-0599-2012 · Posted 2012-01-11
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Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeGKZ
Date Initiated2011-10-13
Date Terminated2012-06-01
Product Quantity117 units total
Reason for Recall
The recall was initiated because Beckman has identified a problem with Integrated Circuit chips used in different boards throughout the analyzer.
Firm Action
Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated October 13, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were instructed to contact Beckman Coulter Service at (800) 526-7694 if they were experiencing failures. Customers not experiencing failures, but their system may have the suspect chips, were told they would be contacted by Beckman Coulter Service to correct their problem. Customers were also instructed to complete and return an enclosed Response Form.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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